Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

First patient was enrolled 28 June 2008 and last patient was enrolled 07 November 2010.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

A total of 258 participants were enrolled, of whom 205 were randomized after 6 months and 53 were not randomized.

Reporting Groups

Description

Non-randomized

Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.

Etanercept Alone

After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.

Etanercept + Methotrexate

After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Non-randomized

Enrolled participants received treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) but discontinued prior to completing this 6 months of treatment.

Etanercept Alone

After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to discontinue methotrexate (tapered over 6 weeks) and continue etanercept alone for an additional 18 months.

Etanercept + Methotrexate

After six months of treatment with 50 mg/week subcutaneous etanercept added to existing methotrexate therapy of at least 15 mg/week (or 10 mg/week in case of documented intolerance to higher doses) participants were randomized to continue both etanercept plus methotrexate for an additional 18 months.

Total

Total of all reporting groups

Baseline Measures

Non-randomized

Etanercept Alone

Etanercept + Methotrexate

Total

Number of Participants
[units: participants]

53

98

107

258

Age
[units: years]Mean ± Standard Deviation

56.2
± 13.4

54.3
± 11.9

54.4
± 12.7

54.7
± 12.5

Gender
[units: participants]

Female

41

72

84

197

Male

12

26

23

61

Race/Ethnicity, Customized
[units: participants]

White or Caucasian

47

96

103

246

Black or African American

2

1

0

3

Hispanic or Latino

0

0

1

1

Asian

2

0

0

2

Native Hawaiian or other Pacific Islander

0

0

3

3

Aborigine

1

0

0

1

Other

1

1

0

2

Duration of rheumatoid arthritis
[units: participants]

< 2 years

11

23

23

57

>= 2 years

42

75

84

201

Reimbursement type
[units: participants]

Private

23

48

55

126

Public

16

33

37

86

Combination/Other

14

17

15

46

Disease Activity Score (DAS28-ESR)
[1][units: participants]

<= 5.1

20

43

41

104

> 5.1

33

55

66

154

[1]

The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • Erythrocyte sedimentation rate (ESR); • Patient's global assessment of disease activity measured on a 100 mm visual analog scale. The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.